A Phase 4 interventional study of Rocuronium and Sugammadex in Tonsillectomy, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Prevention
The goal of this clinical trial is to compare general anesthesia with muscle relaxation and reversal of the relaxation at the end of surgery or without muscle relaxation in high-risk children having adenotonsillectomy surgery. The main questions it aims to answer are:
Participants will wear three additional, noninvasive monitors during surgery, and one additional monitor after surgery. The amount of opioid pain medication required will be tracked, and the patient will be observed postoperatively for breathing complications. Measurements will be collected from the monitor worn postoperatively.
Researchers will compare general anesthesia with muscle relaxation and reversal of relaxation at the end of surgery with general anesthesia without muscle relaxation to test the hypothesis that the approach using muscle relaxation reduces the amount of opioid pain medication required during and after surgery.
This will be a randomized, patient- and assessor-blinded, parallel arm, controlled trial assessing the efficacy of neuromuscular blockade with reversal during the anesthetic management of pediatric adenotonsillectomy (AT) to reduce intra- and postoperative opioid consumption and postoperative respiratory events in high-risk patients. Enrolled participants will be randomized by computer-generated assignment using stratified blocked randomization with a 1:1 allocation into 2 arms: neuromuscular blockade with reversal at the end of surgery and no neuromuscular blockade. Randomization will occur on the following strata: severe versus non-severe obstructive sleep apnea (OSA)/sleep disordered breathing. Patients/families, treating teams (except for the anesthesia team), and research staff/investigators responsible for measuring and adjudicating outcomes will be blinded to allocation.
Primary Efficacy Objective - Evaluate intraoperative and postoperative opioid consumption in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex.
Secondary Objectives - (1) Evaluate postoperative respiratory events in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex. The outcome of postoperative respiratory events will be a composite measure consisting of 1) airway obstruction or hypoxemia, defined as SpO2 less than 90 percent, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated intensive care unit (ICU) admission. (2) Evaluate postoperative low minute ventilation (MV) episodes, defined as MV less than 40 percent predicted for at least 2 minutes and measured by a respiratory volume monitor (RVM), in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 172 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery. SOC drugs: 1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. 2. Sevoflurane induction and maintenance of anesthesia 3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop 4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). 6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours. Device monitoring: 1. Bispectral index system intraop 2. TetraGraph neuromuscular transmission monitor intraop 3. ExSpiron respiratory volume monitor intraop and in PACU
Drug: Rocuronium · Drug: Sugammadex
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered. SOC drugs: 1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. 2. Sevoflurane induction and maintenance of anesthesia 3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop 4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). 6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours. Device monitoring: 1. Bispectral index system intraop 2. ExSpiron respiratory volume monitor intraop and in PACU
Other: Anesthesia without neuromuscular blockade
After induction of anesthesia and placement of an IV, rocuronium 0.6 mg/kg (maximum dose 50mg) will be administered. Additional doses of rocuronium 0.2 mg/kg (maximum dose 15 mg) will be administered when the neuromuscular transmission monitor indicates a train of four count of 2 or greater.
Also known as: Neuromuscular blocking agent, Paralytic, Zemuron, Esmeron, Neuromuscular blocking drug, Nondepolarizing neuromuscular blocker, Nondepolarizing neuromuscular blocking agent, Nondepolarizing neuromuscular blocking drug
When the surgery is completed, sugammadex 2 mg/kg will be administered if the neuromuscular transmission monitor indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.
Also known as: Bridion, Neuromuscular blocking agent reversal, Neuromuscular blocking drug reversal, Paralytic reversal, Nondepolarizing neuromuscular blocking agent reversal, Nondepolarizing neuromuscular blocking drug reversal, Nondepolarizing neuromuscular blocker reversal
Anesthesia without rocuronium or sugammadex
Cumulative Intra- and Postoperative Opioid Consumption
Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight
Time frame: From surgery start to discharge home, up to 24 hours
Number of Participants With Postoperative Respiratory Events
Composite binary outcome consisting of 1) airway obstruction or hypoxemia, defined as SpO2 \<90%, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated ICU admission.
Time frame: From post-anesthesia care unit admission to discharge home, up to 24 hours
Number of Low Minute Ventilation (MV) Events in the Post-anesthesia Care Unit
Count outcome of distinct episodes of low MV. MV - the product of respiratory rate and tidal volume - was continuously measured by a noninvasive respiratory volume monitor. Low MV events were defined as episodes of MV less than 40 percent predicted - calculated by the monitor based on the patient's body surface area - for at least two minutes. This definition is routinely used by the monitoring system.
Time frame: From post-anesthesia care unit admission to transfer to the postoperative ward, up to 8 hours
| Milestone | Neuromuscular Blockade | No Neuromuscular Blockade |
|---|---|---|
| Started | 86 | 86 |
| Completed | 86 | 86 |
| Not completed | 0 | 0 |
Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight
| IV morphine milligram equivalent/kg | Neuromuscular Blockade | No Neuromuscular Blockade |
|---|---|---|
| Cumulative Intra- and Postoperative Opioid Consumption | 0.209 ± 0.009 | 0.188 ± 0.009 |
Composite binary outcome consisting of 1) airway obstruction or hypoxemia, defined as SpO2 \<90%, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated ICU admission.
| Participants | Neuromuscular Blockade | No Neuromuscular Blockade |
|---|---|---|
| Respiratory event PACU or ward | 32 | 38 |
| Respiratory event PACU | 31 | 37 |
| Respiratory event ward | 4 | 10 |
Count outcome of distinct episodes of low MV. MV - the product of respiratory rate and tidal volume - was continuously measured by a noninvasive respiratory volume monitor. Low MV events were defined as episodes of MV less than 40 percent predicted - calculated by the monitor based on the patient's body surface area - for at least two minutes. This definition is routinely used by the monitoring system.
| low minute ventilation events | Neuromuscular Blockade | No Neuromuscular Blockade |
|---|---|---|
| Number of Low Minute Ventilation (MV) Events in the Post-anesthesia Care Unit | 0 (0 to 16) | 0 (0 to 5) |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neuromuscular Blockade | 0/86 (0%) | 0/86 (0%) | 1/86 (1.2%) |
| No Neuromuscular Blockade | 0/86 (0%) | 0/86 (0%) | 1/86 (1.2%) |
| Event | Neuromuscular Blockade | No Neuromuscular Blockade |
|---|---|---|
| Drug reactionRespiratory, thoracic and mediastinal disorders | 1/86 | 0/86 |
| Drug effectRespiratory, thoracic and mediastinal disorders | 0/86 | 1/86 |
| Age, Continuous(years) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| Mean | 5.9 ± 2.9 | 7 ± 3.2 | 6.5 ± 3.1 |
| Sex: Female, Male(Participants) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| Female | 39 | 42 | 81 |
| Male | 47 | 44 | 91 |
| Race/Ethnicity, Customized(participants) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| White | 56 | 54 | 110 |
| Black | 21 | 17 | 38 |
| Other | 9 | 15 | 24 |
| Hispanic | 50 | 69 | 119 |
| Non-Hispanic | 36 | 17 | 53 |
| Obesity(Participants) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| Count of participants | 37 | 54 | 91 |
| Extreme prematurity(Participants) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| Count of participants | 1 | 1 | 2 |
| Upper respiratory infection symptoms(Participants) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| Count of participants | 6 | 4 | 10 |
| Trisomy 21(Participants) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| Count of participants | 2 | 1 | 3 |
| Obstructive sleep apnea severity(Participants) | Neuromuscular Blockade | No Neuromuscular Blockade | Total |
|---|---|---|---|
| No preoperative polysomnogram | 26 | 29 | 55 |
| Mild obstructive sleep apnea | 11 | 5 | 16 |
| Moderate obstructive sleep apnea | 6 | 9 | 15 |
| Severe obstructive sleep apnea | 43 | 43 | 86 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — In accordance with the NIH's Data Management Sharing Policy and recent focus in the scientific community on data sharing, all collected deidentified individual participant data will be stored in the UTSW Data Repository, an open access data repository for researchers affiliated with UTSW.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Starting 6 months after publication, for a period of 5 years
Access criteria: The UT Southwestern Research Data Repository is an open access data repository for researchers affiliated with the UT Southwestern Medical Center. The repository consists of datasets produced by the University community, available for public access and re-use. Each dataset includes citation information and a Digital Object Identifier (DOI), facilitating attribution, usage tracking, and linking of data to research publications. Human research data may only be included if data are deidentified and the IRB has approved the sharing of the data on that repository.
Data sharing details ↗ · dataverse.tdl.org
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Studies of the drugs tested here: Rocuronium · Sugammadex
University of Texas Southwestern Medical Center →